Sensory Toys for Anxiety Reduction - Can Fidget Toys Improve Stress and Help Children to Cope Before Surgery (STARFISH)

Anxiety associated with hospital experiences is common and a key concern for families and clinicians. Anxiety is linked to a number of adverse outcomes in children, including an increased risk of emergence delirium after anaesthesia, increased/prolonged pain, increased medication use (particularly strong pain killers, sedating agents), prolonged hospital stay, negative post-procedural behavioural outcomes, distress to children, families and medical staff, as well as distress to other children and families who witness a child in distress. Furthermore, anxiety can lead to long-term avoidance of healthcare encounters and consequently to negative health outcomes which can be life-long. This avoidance can impact not only the child's health care trajectory but also the health-trajectory and wellbeing of their parents and siblings.

In many institutions, including Perth Children's Hospital (PCH), pharmacological interventions in the form of sedative pre-medication are currently the most common strategy used to manage preoperative anxiety. Midazolam, for example, is a pre-medication widely used to reduce preoperative anxiety. Various studies have displayed the efficacy of midazolam in improving child behaviour during induction and reducing anxiety. Pharmacological interventions, however, have limitations, including the requirement to monitor patients after drug administration for potential adverse side effects and changes in vital signs. This increases staff requirements, placing more pressure on nurses and driving costs upwards. Paediatric patients may even find the process of taking pre-medication more traumatising than the hospital experience itself. Furthermore, while children may seem less anxious during the induction of anaesthesia following premedication with midazolam, research suggests that midazolam can paradoxically increase the incidence of post-hospital behavioural change. Some patients describe feeling anxious inside and "locked in", while from the outside looking calm, increasing their perceived anxiety even more. Additionally, pre-medication does not address the cause of the anxiety or help to develop strategies that may improve a child's ability to cope with stressful circumstances into the future.

A promising strategy that can reduce intense anxiety is distraction, and it has long been recognised that distraction leads to a significant reduction in perioperative anxiety. Distraction can take many forms, and while it is an under-researched area, there is a high potential for involving distraction via sensory experiences.

In this context, the use of sensory toys (e.g., spinners, putty, and stability balls) has been repeatedly suggested by consumers of all ages to aid with anxiety management. The benefit of sensory toys is that they can be used by nearly all children of a certain age group, including many who are neurodiverse, have special needs, and children from diverse cultural backgrounds, languages other than English, and those in regional/remote areas. Previous attempts at delivering tools for children to self-manage symptoms of anxiety have been labour-intensive to implement and train. Although purchasing the sensory toy incurs a cost, it remains a relatively inexpensive intervention that, could be easily implemented to benefit the child beyond the hospital experience. The costs are likely offset by a reduced requirement for premedication and thus a lower requirement for close nursing observation levels and time savings due to fewer theatre delays caused by incorrect timing of premedications.

This randomised controlled multicentre trial will assess the effect of a sensory toy on the child's preoperative anxiety, administered on the day of surgery. It will further assess, the cost of the intervention, the impact on anaesthesia induction, premedication as well as immediate and short term (1 week) outcomes for children undergoing surgery or procedures under general anaesthesia.

• Compare anxiety levels at baseline, sign in to theatre, and at induction of anaesthesia on the day of surgery between the sensory toy group and control group [Срок оценки: Anxiety will be assessed on the day of surgery in the perioperative holding area (T1, in pre-operative holding area), at sign-in to theatre (T2,when patient is moved from ward to induction room) and during induction (T3, when mask or needle is applied)]
• Compare induction compliance between the sensory toy group and the control group on the day of surgery [Срок оценки: Assessed on the day of surgery during anaesthetic induction (application of the mask or the needle)]
• Compare postoperative analgesia requirements between control group and sensory toy group [Срок оценки: Analgesics will be recorded until 24 hours post-surgery or time of discharge, whichever is sooner.]
• Comparison of incidence of emergence delirium between sensory toy and control groups [Срок оценки: Emergence delirium will be assessed after surgery when the child wakes immediately after anaesthesia until discharge from the post-anaesthetic care unit (PACU) on the day of surgery.]
• Compare post-operative behavioural outcomes between control group and sensory toy group [Срок оценки: Assessed on days 1 and 7 post-operatively]
• Assessment of the parental and child satisfaction with the intervention [Срок оценки: Assessed on the day of surgery at sign-out to theatre (patient moved from ward to induction room) or prior to the administration of a sedative premedication; on the post-operative ward before hospital discharge, and at 7 days post-discharge]
• Compare differences in anxiety, induction compliance, post-operative analgesia requirements, emergence delirium and post-operative behavioural outcomes between neurodiverse and neurotypical children [Срок оценки: Neurodiversity will be assessed by a researcher via a questionnaire administered prior to surgery.]
• Compare incidence of emergence delirium between patients in the sensory toy group and control group [Срок оценки: Emergence delirium will be assessed after surgery when the child wakes immediately after anaesthesia until discharge from the post-anaesthetic care unit (PACU) on the day of surgery.]
• Compare incidence of perioperative respiratory adverse events (PRAE) and post-operative nausea and vomiting (PONV) between neurodiverse and neurotypical children [Срок оценки: PRAE will be assessed by the anaesthetist during anaesthetic induction, maintenance and emergence and by the recovery nurse while in the post-anaesthetic care unit (PACU). PONV will be assessed from waking in PACU until 24 hours post-surgery or discharge]
• Compare the post-operative behavioural outcomes between patients in the sensory toy group and control group using the Paediatric Scale for Quality of Recovery (PedSQoR). [Срок оценки: Assessed 1 day and 7 days post- surgery]
• Compare anxiety levels a baseline, sign in to theatre and at induction of anaesthesia on the day of surgery between neurodiverse and neurotypical children [Срок оценки: Anxiety will be assessed on the day of surgery in the perioperative holding area (T1, in pre-opeative ward), at sign-in to theatre (T2, when patient is moved from ward to induction room) and during induction (T3, when mask or needle is applied).]
• Compare induction compliance on the day of surgery between neurodiverse and neurotypical children [Срок оценки: Assessed on the day of surgery during anaesthetic induction]